History has witnessed numerous drug patent wars, but in April 2013, the Indian Supreme Court did something which captured the attention of the international media. It denied a patent to the beta crystalline form of Imatinib mesylate, a life saving anticancer drug, to the Swiss pharmaceutical company Novartis. The verdict was noteworthy because this drug is patented in more than 38 countries including the US, Russia, and China. Today this drug is being manufactured by generic drug companies in India. Is this a victory against the monopoly of pharmaceutical giants, or has India set a dangerous precedent which will discourage the innovation of future drugs?
As a researcher myself, I understand the importance of patent protection for any intellectual property. Patents give exclusive rights to the innovators for a limited period of time which acts as an incentive for future research and development (R&D). According to estimates, a company spends between US$ 500 million to US$ 2 billion for the discovery, research, testing, and marketing of a new drug. [1] In addition, patents encourage innovators to make their discoveries available for public use.
So why did the court rule against these relevant arguments?
Patentability of a product relies heavily on its novelty. The court argued that the product was not unique, but merely a tweaked version of an already known compound, noting that Imatinib was patented in many countries in 1996. Many researchers are making similar observations about other pharmacological agents and accusing the companies of “evergreening,” a practice which enables them to claim a new patent by slightly modifying the chemical composition of a known drug. Recently an article in the BMJ pointed out that about 85-90% of all new drugs since the mid 90s provide few or no clinical advantages for patients. [2] Even Brian Druker, who developed the beta version of Imatinib, believes in the need for novel, and not just modified drugs.
After the court’s decision, Novartis said it would pull out all R&D investments from India. It should be noted that India has never been a home to new drug discoveries as its priority is to provide cheap medicines to as many people possible. In other words, India has a different role to play in the pharmaceutical industry. India is a major market for manufacturing drugs in their generic form and providing them cheaply to patients in India as well as in other developing and poor countries. For instance, a 400mg pill of the drug in question is being manufactured by Novartis at US$99 each and the same by a generic drug manufacturer at a cost of around US$9. [3] No wonder Médecins Sans Frontières and other charitable health organisations hailed the court’s decision. This brings us to the question of affordability. 81% of the Indians live on less than US$2.5 a day. Predatory pricing and a market monopoly will make healthcare costlier for those living in the developing world as well as for those struggling in the developed. We do not want life saving drugs to be luxury goods.
It has been argued that stricter patent laws will encourage innovation. This is true to some extent as innovators will then be forced to push their limits to develop novel and better products. But we cannot afford to overstretch the strings. If the innovators are denied of their deserved rights and royalties, the intent to discover and invent will die. Some suggested that pharmaceutical companies should act morally and take into account the economic condition of the country they are selling in before pricing their products.
Coming back to our initial question: do we need tougher drug patent laws? There is no simple answer to this. Patients’ interests come first and they must be provided with the best medicines at an affordable price but we also need to incentivise the innovative thinking. A consensus on this patent vs patient issue can only be achieved by debate and discussion.
Mohit Sharma is a doctor from India. He went to medical school at the Medical College Baroda, India and his clinical interests include Neurology and Infectious Diseases. Currently, he is a researcher in the Department of Neurology at State University of New York (SUNY) Downstate Medical Center, Brooklyn and my research interests include Prehospital Identification of Stroke and Emergency Medical Services.
I declare that that I have read and understood the BMJ Group policy on declaration of interests and I have no relevant interests to declare.
1. Adams CP, Brantner VV. Estimating the cost of new drug development: is it really 802 million dollars? Health Aff (Millwood) 2006 Mar-Apr;25(2):420-8.
2. Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? BMJ 2012;345:e4348.
3. Online Drug Prices. Available online at: http://www.canadadrugsonline.com/DrugMoreInfo505.aspx